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临床试验/NCT01513408
NCT01513408进行中(未招募)不适用

Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

Centre Georges Francois Leclerc2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
2
主要终点
Overall survival

研究概览

简要总结

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: From date of inclusion up to the end of follow-up period : december 2014 (anticipated)

Overall survival is defined as the time from inclusion date to death from any cause, or to date of last follow-up, if death does not occur.

次要结局

  • Pathological complete response(After surgery)
  • Recurrence-free survival(From inclusion up to the end of follow up period: december 2014)
  • PathIm score (pathological-immunological)(From inclusion up to the end of surgery for all patients: december 2014 (anticipated))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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